NCT02526277

A Study on the Use of the MMF07 Foot Massager and Heat Therapy Treatments for Restless Leg Syndrome

A Randomized Prospective Study on the Efficacy of the MMF07 Foot Massager and Heat Therapy Treatments for Restless Leg Syndrome

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Ariane Park · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess whether the MMF07 Foot Massager and/ or heat therapy may improve symptoms of restless legs syndrome (RLS). It will also assess the effect of the MMF07 Foot Massager and/ or heat on quality of life and sleep in people affected by RLS. Participants will be randomly assigned to one of four treatment groups; 1. MMF07 Foot Massager device 2. Heat therapy 3. Heat therapy and the MMF07 Foot Massage device 4. Neither heat nor MMF07 Foot Massager device (no treatment group)

Detailed description

Few clinical trials have looked into non-pharmacological, non-invasive treatments for restless legs syndrome, despite reports that massage, baths and vibrations can alleviate RLS symptoms. We would like to assess whether the MMF007 Foot Massager device and/or heat therapy is associated with improved severity of RLS symptoms. For this study the investigator will enroll 40 participants who have been diagnosed with restless legs syndrome, who will be followed over the course of four weeks and asked to complete two in person study visits. In the study the investigator is comparing the use of the MMF007 Foot Massager device and/ or heat therapy to a non treatment group to assess if the symptoms of RLS improve.

Conditions

• Restless Legs Syndrome

Interventions

Type	Name	Description
DEVICE	MMF07 Foot Massager
DEVICE	Heat Therapy

Timeline

• Start date: 2016-01-06
• Primary completion: 2018-09-25
• Completion: 2018-09-25
• First posted: 2015-08-18
• Last updated: 2021-01-28
• Results posted: 2020-02-18

Locations

1 site across 1 country: United States